N-nitroso-hydrochlorothiazide limit


Due to the recent update of the nitrosamine guideline ( rev 17) which has become effective from 29. July 2023, the limit for N-nitroso-hydrochlorothiazide has been set to NMI. This means that a limit should be applied based on the ICHQ3B. Can somebody help me explain how we should calculate the limit of a drug containing API N-nitroso-hydrochlorothiazide based on ICHQ3B ? Thank you.-

Hi Amina,

I suggest reviewing the guidance itself and their reporting and analytical considerations